Dual long-acting cabotegravir/rilpivirine injection submitted to FDA
Simon Collins, HIV i-Base
On 29 April 2019, ViiV Healthcare announced that the long-acting two-drug injection formulation of cabotegravir/rilpivirine has been submitted to the US FDA. 
This announcement was expected following the presentation at CROI 2019 last month of the primary endpoint results from the phase 3 FLAIR and ATLAS studies. 
These studies reported >90% viral suppression <50 copies/mL at week-48 meeting criteria for non-inferiority compared to three-drug oral therapy.
The press release also notes that submission to the European Medicines Agency (EMA) is expected within the next few months.
- ViiV press statement. ViiV Healthcare submits New Drug Application to US FDA for the first monthly, injectable, two-drug regimen of cabotegravir and rilpivirine. (29 April 2019).
https://www.viivhealthcare.com/en-gb/media (direct link)
- Collins S. Phase 3 results with dual therapy cabotegravir/rilpivirine long-acting injections: ATLAS and FLAIR studies. HTB: 20(4), 12 March 2019.